Irritable bowel syndrome (Blautix)
In 2016 we completed a Phase Ib study of Blautix, our live biotherapeutic candidate for irritable bowel syndrome. The trial was a placebo-controlled study and enrolled 24 IBS patients and 24 healthy volunteers.
The study met its primary objective of demonstrating that Blautix was safe and well tolerated. We were also able to obtain preliminary insights into the clinical effectiveness and mechanism of the drug. Encouragingly, we saw a greater proportion of Blautix-treated patients showing improvements in their IBS symptoms compared with patients receiving placebo. We also noted a greater proportion of the Blautix treatment group exhibiting a reduction in hydrogen breath levels – a biomarker of the drug’s activity.
Although based on a relatively small sample size, these observations are in line with preclinical data and strengthen the evidence of the proposed mechanism of action for Blautix in the treatment of IBS. Moreover, these encouraging early clinical results provide a solid basis for progressing Blautix into larger studies and further evaluation as a potential treatment for IBS.
Paediatric Crohn’s disease (Thetanix)
We commenced dosing of our first in man study of Thetanix in August 2016. The trial will investigate primarily the safety and tolerability but also provide initial insights into the clinical efficacy of Thetanix in 20 paediatric patients with Crohn’s disease.